The skin or integument is a major organ of the body present as a specialized boundary lamina, covering essentially the entire external surface of the body, except for the mucosal surfaces. It forms about 8% of the body mass with a thickness ranging from about 1.5 to about 4 mm. Structurally, the skin organ is complex and highly specialized as is evidenced by its ability to provide a barrier against microbial invasion and dehydration, regulate thermal exchange, act as a complex sensory surface, and provide for wound healing wherein the epidermis responds by regeneration and the underlying dermis responds by repair (inflammation, proliferation, and remodeling), among a variety of other essential functions.
Medical specialties have evolved with respect to the skin, classically in connection with restorative and aesthetic (plastic) surgery. Such latter endeavors typically involve human aging. The major features of the skin are essentially formed before birth and within the initial two to three decades of life are observed to not only expand in surface area but also in thickness. From about the third decade of life onward there is a gradual change in appearance and mechanical properties of the skin reflective of anatomical and biological changes related to natural aging processes of the body. Such changes include a thinning of the adipose tissue underlying the dermis, a decrease in the collagen content of the dermis, changes in the molecular collagen composition of the dermis, increases in the number of wrinkles, along with additional changes in skin composition. The dermis itself decreases in bulk, and wrinkling of senescent skin is almost entirely related to changes in the dermis. Importantly, age related changes in the number, diameter, and arrangement of collagen fibers are correlated with a decrease in the tensile strength of aging skin in the human body, and the extensibility and elasticity of skin decrease with age. Evidence indicates that intrinsically aged skin shows morphological changes that are similar in a number of features to skin aged by environmental factors, including photoaging.
See generally:                1. Gray's Anatomy, 39th Edition, Churchill Livingstone, N.Y. (2005)        2. Rook's Textbook of Dermatology, 7th Edition, Blackwell Science, Malden, Mass. (2004)        
A substantial population of individuals seeking to ameliorate this aging process has evolved over the decades. For instance, beginning in the late 1980s researchers who had focused primarily on treating or curing disease began studying healthy skin and ways to improve it and as a consequence, a substantial industry has evolved. By reducing and inhibiting wrinkles and minimizing the effects of ptosis (skin laxity and sagging skin) caused by the natural aging of collagen fibrils within the dermis, facial improvements have been realized with the evolution of a broad variety of corrective approaches.
Considering its structure from a microscopic standpoint, the skin is composed of two primary layers, an outer epidermis which is a keratinized stratified squamous epithelium, and the supporting dermis which is highly vascularized and provides supporting functions. In the epidermis tissue there is a continuous and progressive replacement of cells, with a mitotic layer at the base replacing cells shed at the surface. Beneath the epidermis is the dermis, a moderately dense connective tissue. The epidermis and dermis are connected by a basement membrane or basal lamina with greater thickness formed as a collagen fiber which is considered a Type I collagen having an attribute of shrinking under certain chemical or heat influences. Lastly, the dermis resides generally over a layer of contour defining subcutaneous fat. Early and some current approaches to the rejuvenation have looked to treatments directed principally to the epidermis, an approach generally referred to ablative resurfacing of the skin. Ablative resurfacing of the skin has been carried out with a variety of techniques. One approach, referred to as “dermabrasion” in effect mechanically grinds off components of the epidermis.
Mechanical dermabrasion activities reach far back in history. It is reported that about 1500 B.C. Egyptian physicians used sandpaper to smooth scars. In 1905 a motorized dermabrasion was introduced. In 1953 powered dental equipment was modified to carry out dermabrasion practices. See generally:                3. Lawrence, et al., “History of Dermabrasion” Dermatol Surg 2000; 26:95-101        
A corresponding chemical approach is referred to by dermatologists as “chemical peel”. See generally:                4. Moy, et al., “Comparison of the Effect of Various Chemical Peeling Agents in a Mini-Pig Model” Dermatol Surg 1996; 22:429-432        
Another approach, referred to as “laser ablative resurfacing of skin” initially employed a pulsed CO2 laser to repair photo-damaged tissue which removed the epidermis and caused residual thermal damage within the dermis. It is reported that patients typically experienced significant side effects following this ablative skin resurfacing treatment. Avoiding side effects, non-ablative dermal remodeling was developed wherein laser treatment was combined with timed superficial skin cooling to repair tissue defects related to photo-aging. Epidermal removal or damage thus was avoided, however, the techniques have been described as having limited efficacy. More recently, fractional photothermolysis has been introduced wherein a laser is employed to fire short, low energy bursts in a matrix pattern of non-continuous points to form a rastor-like pattern. This pattern is a formation of isolated non-continuous micro-thermal wounds creating necrotic zones surrounded by zones of viable tissue. See generally:                5. Manstein, et al., “Fractional Photothermolysis: A New Concept for Cutaneous Remodeling Using Microscopic Patterns of Thermal Injury”; Lasers in Surgery and Medicine 34:426-438 (2004)        
These ablative techniques (some investigators consider fractional photothermolysis as a separate approach) are associated with drawbacks. For instance, the resultant insult to the skin may require 4-6 months or more of healing to evolve newer looking skin. That newer looking skin will not necessarily exhibit the same shade or coloration as its original counterpart. In general, there is no modification of the dermis in terms of a treatment for ptosis or skin laxity through collagen shrinkage.
To treat patients for skin laxity, some investigators have looked to procedures other than plastic surgery. Techniques for induced collagen shrinkage at the dermis have been developed. Such shrinkage qualities of collagen have been known and used for hundreds of years, the most classic example being the shrinking of heads by South American headhunters. Commencing in the early 1900s shrinking of collagen has been used as a quantitative measure of tanning with respect to leather and in the evaluation of glues See:                6. Rasmussen, et al., “Isotonic and Isometric Thermal Contraction of Human Dermis I. Technic and Controlled Study”, J. Invest. Derm. 1964; 43:333-9        
Dermis has been heated through the epidermis utilizing laser technology as well as intense pulsed light exhibiting various light spectra or single wavelength. The procedure involves spraying a burst of coolant upon the skin such as refrigerated air, whereupon a burst of photons penetrates the epidermis and delivers energy into the dermis.
Treatment for skin laxity by causing a shrinkage of collagen within the dermis generally involves a heating of the dermis to a temperature of about 60° C. to 70° C. over a designed treatment interval. Heat induced shrinkage has been observed in a course of laser dermabrasion procedures. However, the resultant energy deposition within the epidermis has caused the surface of the skin to be ablated (i.e., burned off the surface of the underlying dermis) exposing the patient to painful recovery and extended healing periods which can be as long as 6-12 months. See the following publication:                7. Fitzpatrick, et al., “Collagen Tightening Induced by Carbon Dioxide Laser Versus Erbium: YAG Laser” Lasers in Surgery and Medicine 27: 395-403 (2000)        
Dermal heating in consequence of the controlled application of energy in the form of light or radiofrequency electrical current through the epidermis and into the dermis has been introduced. To avoid injury to the epidermis, cooling methods have been employed to simultaneously cool the epidermis while transmitting energy through it. In general, these approaches have resulted in uncontrolled, non-uniform and often inadequate heating of the dermis layer resulting in either under-heating (insufficient collagen shrinkage) or over-heating (thermal injury) to the subcutaneous fat layer and/or weakening of collagen fibrils due to over-shrinkage. See the following publication:                8. Fitzpatrick, et al., “Multicenter Study of Noninvasive Radiofrequency for Periorbital Tissue Tightening”, Lasers in Surgery in Medicine 33:232-242 (2003)        
The RF approach described in publication 8 above is further described in U.S. Pat. Nos. 6,241,753; 6,311,090; 6,381,498; and 6,405,090. Such procedure involves the use of an electrode capacitively coupled to the skin surface which causes radiofrequency current to flow through the skin to a much larger return electrode located remotely upon the skin surface of the patient. Note that the electrodes are positioned against skin surface and not beneath it. The radiofrequency current density caused to flow through the skin is selected to be sufficiently high to cause resistance heating within the tissue and reach temperatures sufficiently high to cause collagen shrinkage and thermal injury, the latter result stimulating beneficial growth of new collagen, a reaction generally referred to as “neocollagenasis”.
To minimize thermal energy to the underlying subcutaneous fat layer these heating methods also attempt to apply energy periods with pulse durations on the order of several nanoseconds to several thousand microseconds for laser based methods and several seconds for radiofrequency electrical current based methods. This highly transient approach to heating the collagen within the dermis also leads to a wide range of temperature variations due to natural patient-to-patient differences in the optical and electrical properties of their skin including localized variations in electrical properties of skin layers. It may be observed that the electrical properties of the dermis are not necessarily homogenous and may vary somewhat within the treatment zone, for example, because of regions of concentrated vascularity. This may jeopardize the integrity of the underlying fat layer and damage it resulting in a loss of desired facial contour. Such unfortunate result at present appears to be uncorrectable. Accordingly, uniform heating of the dermal layer is called for in the presence of an assurance that the underlying fat layer is not affected while minimal injury to the epidermis is achieved. A discussion of the outcome and complications of the noted non-ablative mono-polar radiofrequency treatment is provided in the following publication:                9. Abraham, et al., “Current Concepts in Nonablative Radiofrequency Rejuvenation of the Lower Face and Neck” Facial Plastic Surgery, Vol. 21 No. 1 (2005)        
In the late 1990s, Sulamanidze developed a mechanical technique for correcting skin laxity. With this approach one or more barbed non-resorbable sutures are threaded under the skin with an elongate needle. The result is retention of the skin in a contracted state and, over an interval of time, the adjacent tissue will ingrow around the suture to stabilize the facial correction. See the following publications:                10. Sulamanidze, et al., “Removal of Facial Soft Tissue Ptosis With Special Threads”, Dermatol Surg; 28:367-371 (2002)        11. Lycka, et al., “The Emerging Technique of the Antiptosis Subdermal Suspension Thread”, Dermatol Surg; 30:41-44 (2004)        
Eggers, et al., in application for U.S. patent Ser. No. 11/298,420 entitled “Aesthetic Thermal Sculpting of Skin”, filed Dec. 9, 2005 describes a technique for directly applying heat energy to dermis with one or more elevated temperature implants providing controlled shrinkage thereof. Importantly, while this heating procedure is underway, the subcutaneous fat layer is protected by a polymeric thermal barrier. In a preferred arrangement this barrier implant is thin and elongate and supports a flexible resistive heating circuit, the metal heating components of which are in direct contact with dermis. Temperature output of this resistive heating circuit is intermittently monitored and controlled by measurement of a monitor value of resistance. For instance, resistive heating is carried out for about a one hundred millisecond interval interspersed with one millisecond resistance measurement intervals. Treatment intervals experienced with this system and technique will appear to obtain significant collagen shrinkage within about ten minutes to about fifteen minutes. During the procedure, the epidermis is cooled by blown air.
Dermis also is the situs of congenital birthmarks generally deemed to be capillary malformations historically referred to as “Port-Wine Stains” (PWS). Ranging in coloration from pink to purple, these non-proliferative lesions are characterized histologically by ecstatic vessels of capillary or venular type within the papillary and reticular dermis and are considered as a type of vascular malformation. The macular lesions are relatively rare, occurring in about 0.3% of newborns and generally appear on the skin of the head and neck within the distribution of the trigeminal (fifth cranial) nerve. They persist throughout life and may become raised, nodular, or darken with age. Their depth has been measured utilizing pulsed photothermal radiometry (PPTR) and ranges from about 200 μm to greater than 1,000 μm.
See the following publication:                12. Bincheng, et al., Accurate Measurement of Blood Vessel Depth in Port Wine Stain Human Skin in vivo Using “Photothermal Radiometry”, J. Biomed. Opt. (5), 961-966 (September/October 2004).        
Fading or lightening the PWS lesions has been carried out with lasers with somewhat mixed results. For instance, they have been treated with pulsed dye lasers (PDL) at 585 mm wavelength with a 0.45 ms pulse length and 5 mm diameter spot size. Cryogenic bursts have been used with the pulsing for epidermal protection. Generally, the extent of lightening achieved is evaluated six to eight weeks following laser treatment. Such evaluation assigns the color of adjacent normal skin as 100% lightening and a post clearance, evaluation of lesions will consider more than 75% lightening as good.
See the following publication:                13. Fiskerstrand, et al., “Laser Treatment of Port Wine Stains:        
Thereaupetic Outcome in Relation to Morphological Parameters”, Brit. J. of Derm., 134, 1039-1043, (1996).
Lesions have been classified, for instance, utilizing video microscopy, three patterns of vascular ectasia being established; type 1, ectasia of the vertical loops of the papillary plexus; type 2, ectasia of the deeper, horizontal vessels in the papillary plexus; and type 3, mixed pattern with varying degrees of vertical and horizontal vascular ectasia. In general, due to the limited depth of laser therapy, only type 1 lesions are apt to respond to such therapy.
Port wine stains also are classified in accordance with their degree of vascular ectasia, four grades thereof being recognized, Grades I to IV.
Grade 1 lesions are the earliest lesions and thus have the smallest vessels (50-80 um in diameter). Using ×6 magnification and transillumination, individual vessels can only just be discerned and appear like grains of sand. Clinically, these lesions are light or dark pink macules. Grade II lesions are more advanced (vessel diameter=80-120 um). Individual vessels are clearly visible to the naked eye, especially in less dense areas. They are thus clearly distinguishable macules. Grade III lesions are more ecstatic (120-150 um). By this stage, the space between the vessels has been replaced by the dilated vessels. Individual vessels may still be visible on the edges of the lesion or in a less dense lesion, but by and large individual vessels are no longer visible. The lesion is usually thick, purple, and palpable. Eventually dilated vessels will coalesce to form nodules, otherwise known as cobblestones. Grade IV represents the largest vessels. The main purpose of these classifications has been to assign a grade for ease in communication and determination of the appropriate laser treatment settings.
See the following publication:                14. Mihm, Jr., et al, “Science, Math and Medicine—Working Together to Understand the Diagnosis, Classification and Treatment of Port-Wine Stains”, a paper presented in Mt. Tremblant, Quebec, Canada, 2004, Controversies and Conversations in Cutaneous Laser Surgery—An Advanced Symposium.        